2016
Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study
Abstract: Summary Background Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre‐registration studies. Aim To confirm these clinical trial findings in the treatment of genotype 1 and 4 hepatitis C under real‐world conditions. Methods Patients enrolled for treatment with OBV/PTV/r ± DSV ± RBV based on therapeutic guidelines were included, …
Search citation statements
Paper Sections
Select...
59
38
21
4
Citation Types
30
87
1
7
Year Published
2016
2025
Publication Types
Select...
98
4
2
Relationship
2
102
Authors
Journals
Cited by 104 publications
(125 citation statements)
References 23 publications
30
87
1
7
“…The presented real-life data showed very high efficacy (100% ETR and 98.9% SVR12) of the new DAAs (OBV/PTV/RTV + DSV + RBV) in patients with chronic HCV infection. This is in full accordance with results of other studies [9][10][11][12][13] .…”
Section: Discussionsupporting
confidence: 93%
“…The presented real-life data showed very high efficacy (100% ETR and 98.9% SVR12) of the new DAAs (OBV/PTV/RTV + DSV + RBV) in patients with chronic HCV infection. This is in full accordance with results of other studies [9][10][11][12][13] .…”
Section: Discussionsupporting
confidence: 93%
“…This is in full accordance with European 9,10,14 and US real-world data 15 where predominant type was also genotype 1, while in RVR data suggest very rapid onset of action of DAAs with null viraemia in 91.66% of available patients. This result is in line with the Polish study were RVR was achieved in 69.23% 10 . ETR and SVR data showed 100% direct antiviral effectiveness of the used therapeutic regimen which was partly due to the well preserved hepatic function.…”
Section: Discussionsupporting
confidence: 93%
“…Regarding the safety profile of OBV/PTV/r + DSV therapy, the majority of adverse events were mild, and strongly associated with use of RBV. Pruritus, nausea, headache, and asthenia were the most common adverse events, in agreement with the results of previous clinical trials and real‐life studies . In our study, hyperbilirubinemia and anemia were also present in patients with RBV co‐administration but no ALT elevation was reported.…”
Section: Discussionsupporting
confidence: 92%
“…Our study is in accordance with previous real-life studies investigating the efficacy of OBV/PTV/r+DSV±RBV in chronic hepatitis C patients [9][10][11][12][17][18][19] with SVR rates between 86% and 100%. In real-life cohorts, patients who failed to achieve SVR were mainly cirrhotics [9][10][17][18]. In the study of Fox et al [17], SVR rates were lower for patients <65years, with cirrhosis, HCC, or a GT-non-1 infection.…”
Section: Discussionsupporting
confidence: 92%
